Post by icemandios on Mar 27, 2023 13:35:42 GMT
US Expert Panel to Meet to Determine Which Adverse Events COVID-19 Vaccines Cause
Vaccines & Safety
Zachary Stieber
Zachary Stieber, Reporter
A person receives a COVID-19 vaccine in New York City on Oct. 21, 2021. (Michael M. Santiago/Getty Images)
A group of U.S. experts is set to meet soon as part of a project to determine which adverse events the COVID-19 vaccines cause.
The National Academies of Sciences, Engineering, and Medicine (NASEM) has appointed a committee to review evidence on the relationship between the vaccines and specific adverse events that have occurred after vaccination, including infertility and sudden death.
The committee’s process includes establishing methods, reviewing literature, drawing conclusions, and preparing a report.
“The committee will make conclusions about the causal association between vaccines and specific adverse events,” the NASEM website states.
Vaccines & Safety
Zachary Stieber
Zachary Stieber, Reporter
Mar 25 2023
A group of U.S. experts is set to meet soon as part of a project to determine which adverse events the COVID-19 vaccines cause.
The National Academies of Sciences, Engineering, and Medicine (NASEM) has appointed a committee to review evidence on the relationship between the vaccines and specific adverse events that have occurred after vaccination, including infertility and sudden death.
The committee’s process includes establishing methods, reviewing literature, drawing conclusions, and preparing a report.
“The committee will make conclusions about the causal association between vaccines and specific adverse events,” the NASEM website states.
While their work is funded by the U.S. Centers for Disease Control (CDC) and the U.S. Department of Health and Human Services (HHS), the sponsors will not be able to examine the report before it is published to the public, Kathleen Stratton, a NASEM official, said during a recent meeting.
“What that means is that if a sponsor doesn’t like what the committee has to say—the conclusions of the committee—… the sponsor can’t prevent the report from being made public,” Stratton said. “This is a very powerful tool that we have.”
Dr. Tom Shimabukuro, a CDC official, told panel members recently that the CDC would help members locate studies and data from the agency. “We very much value your expertise and your independence. We look forward to working with you, look forward to seeing the results of your findings,” he said.
The upcoming meeting will be held on March 27 and March 31, the latter of which will include time for public comments. The rest of the two-day meeting will be held behind closed doors.
The panel already met on Jan. 25 and Feb. 1.
“Your conclusions will help inform injury compensation recommendations and decisions when assessing whether specific adverse events are causally associated with vaccines,” Dr. George Reed Grimes, the official in charge of the HHS Division of Injury Compensation Programs, told panel members during the meeting.
The report is slated to be published in March 2024.
Dr. Tom Shimabukuro, a CDC official, told panel members recently that the CDC would help members locate studies and data from the agency. “We very much value your expertise and your independence. We look forward to working with you, look forward to seeing the results of your findings,” he said.
The upcoming meeting will be held on March 27 and March 31, the latter of which will include time for public comments. The rest of the two-day meeting will be held behind closed doors.
The panel already met on Jan. 25 and Feb. 1.
“Your conclusions will help inform injury compensation recommendations and decisions when assessing whether specific adverse events are causally associated with vaccines,” Dr. George Reed Grimes, the official in charge of the HHS Division of Injury Compensation Programs, told panel members during the meeting.
The report is slated to be published in March 2024.
Specific Issues
HHS officials directed NASEM to convene the ad hoc committee to review “the epidemiological, clinical, and biological evidence” in assessing whether the vaccines cause certain conditions.
The adverse events include conditions that officials already say are caused by one or more of the vaccines, including myocarditis, a type of heart inflammation caused by all four of the vaccines available in the United States, and thrombosis with thrombocytopenia syndrome, an often-fatal condition caused by the Johnson & Johnson vaccine.
The other specific events are:
Bell’s Palsy
Capillary leak syndrome
Chronic headaches
Chronic inflammatory demyelinating polyneuropathy
Guillain-Barrè Syndrome
Hearing loss
Infertility
Shoulder injuries
Sudden death
Thromboembolic events like pulmonary embolism
Tinnitus
Transverse myelitis
A NASEM panel last produced a vaccine adverse event report in 2012. The report ran nearly 900 pages.
Grimes said HHS officials view that report as an important document. “It is really something we leaned heavily on,” he said.
The new panel is made of entirely new members. They include Dr. Anne Bass, professor of clinical medicine at Weill Cornell Medicine; Dr. Chandy John, director of the Ryan White Center for Pediatric Infectious Diseases and Global Health at Indiana University; and Dr. Thomas Ortel, chief of hematology and professor of medicine and pathology at Duke University.
The report will be peer reviewed before being published. The reviewers will be named in the report. Reviewers last time included Steven Black of Cincinnati Children’s Hospital; Sam Shekar of Northrop Grumman; and Chris Wilson of the Bill & Melinda Gates Foundation.
HHS officials directed NASEM to convene the ad hoc committee to review “the epidemiological, clinical, and biological evidence” in assessing whether the vaccines cause certain conditions.
The adverse events include conditions that officials already say are caused by one or more of the vaccines, including myocarditis, a type of heart inflammation caused by all four of the vaccines available in the United States, and thrombosis with thrombocytopenia syndrome, an often-fatal condition caused by the Johnson & Johnson vaccine.
The other specific events are:
Bell’s Palsy
Capillary leak syndrome
Chronic headaches
Chronic inflammatory demyelinating polyneuropathy
Guillain-Barrè Syndrome
Hearing loss
Infertility
Shoulder injuries
Sudden death
Thromboembolic events like pulmonary embolism
Tinnitus
Transverse myelitis
A NASEM panel last produced a vaccine adverse event report in 2012. The report ran nearly 900 pages.
Grimes said HHS officials view that report as an important document. “It is really something we leaned heavily on,” he said.
The new panel is made of entirely new members. They include Dr. Anne Bass, professor of clinical medicine at Weill Cornell Medicine; Dr. Chandy John, director of the Ryan White Center for Pediatric Infectious Diseases and Global Health at Indiana University; and Dr. Thomas Ortel, chief of hematology and professor of medicine and pathology at Duke University.
The report will be peer reviewed before being published. The reviewers will be named in the report. Reviewers last time included Steven Black of Cincinnati Children’s Hospital; Sam Shekar of Northrop Grumman; and Chris Wilson of the Bill & Melinda Gates Foundation.
Might Help Shift in Compensation
Zero people injured by the COVID-19 vaccines in the United States have been paid.
Because the vaccines are covered under the Public Readiness and Emergency Preparedness Act, injured people, and relatives of those who were killed, must go to the Countermeasures Injury Compensation Program for compensation.
The program rejects most claims. It has only approved to date cases of myocarditis or pericarditis, severe allergic shock, and a skin condition called angiodema.
The Vaccine Injury Compensation Program, another program, covers most vaccines administered in the country. To be covered by that program, three steps must be taken.
The first step has already happened. The CDC has already recommended the vaccine be routinely administered to children and pregnant women. The second step is Congress approving an excise tax, which helps fund the compensation program. The third step is the health secretary publishing a notice that the vaccine would be added to the Vaccine Injury Table, which is used by the program.
The NASEM report will not recommend adding specific injuries to the table, Stratton, who was involved with the 2012 report, said. The report will go to the Advisory Commission for Childhood Vaccines, which “is likely to consider the report findings and potentially make recommendations to add any associated injuries to the vaccine injury table,” according to the National Vaccine Information Center. If that happens, then the only remaining step for the compensation shifting would be Congress approving an excise tax.
Zero people injured by the COVID-19 vaccines in the United States have been paid.
Because the vaccines are covered under the Public Readiness and Emergency Preparedness Act, injured people, and relatives of those who were killed, must go to the Countermeasures Injury Compensation Program for compensation.
The program rejects most claims. It has only approved to date cases of myocarditis or pericarditis, severe allergic shock, and a skin condition called angiodema.
The Vaccine Injury Compensation Program, another program, covers most vaccines administered in the country. To be covered by that program, three steps must be taken.
The first step has already happened. The CDC has already recommended the vaccine be routinely administered to children and pregnant women. The second step is Congress approving an excise tax, which helps fund the compensation program. The third step is the health secretary publishing a notice that the vaccine would be added to the Vaccine Injury Table, which is used by the program.
The NASEM report will not recommend adding specific injuries to the table, Stratton, who was involved with the 2012 report, said. The report will go to the Advisory Commission for Childhood Vaccines, which “is likely to consider the report findings and potentially make recommendations to add any associated injuries to the vaccine injury table,” according to the National Vaccine Information Center. If that happens, then the only remaining step for the compensation shifting would be Congress approving an excise tax.
